Gentium S.p.A. Announces MAA for Defibrotide Accepted by EMA and Will be Reviewed by CHMP Under Accelerated Assessment
6/1/2011 10:38:03 AM
VILLA GUARDIA (COMO), Italy, June 1, 2011 (GLOBE NEWSWIRE) -- Gentium S.p.A. (Nasdaq:GENT) (the "Company") announced today that its Marketing Authorization Application (MAA) seeking approval of Defibrotide for the prevention and treatment of hepatic veno-occlusive disease (VOD) following stem-cell transplantation has been accepted for review by the European Medicines Agency (EMA). Acceptance of the MAA indicates that the application is complete and initiates the regulatory review process by the Committee for Medicinal Products for Human Use (CHMP). CHMP has agreed to the Company's request for an accelerated assessment of the MAA. Under accelerated assessment, the review timeline of the MAA is shortened from 210 to 150 days.